bioLytical’s Syphilis Test Gains Approval in Australia’s ARTG

bioLytical Laboratories Inc. has announced that its iStatis Syphilis Antibody Test is now officially included in the Australian Register of Therapeutic Goods (ARTG: 515126). This regulatory approval, confirmed on October 12, 2025, enables the distribution of the test to healthcare professionals throughout Australia, enhancing the country’s ability to conduct rapid and reliable syphilis screenings.

According to Robert Mackie, CEO of bioLytical, the inclusion of the iStatis test comes at a critical time as Australia faces rising syphilis rates, especially in areas with limited access to regular healthcare. “By providing an accurate, easy-to-use rapid test, we can support healthcare professionals in identifying infections earlier and connecting patients to treatment faster,” Mackie stated.

Overview of the iStatis Syphilis Antibody Test

The iStatis Syphilis Antibody Test operates as a lateral flow assay, detecting antibodies to Treponema pallidum, the bacterium responsible for syphilis. By utilizing a small fingerstick blood sample, the test delivers results in under 15 minutes, allowing healthcare providers to make prompt clinical decisions. This rapid testing capability is crucial for effective syphilis management and control.

The significance of rapid syphilis testing extends beyond individual patient care. It plays a vital role in supporting public health initiatives aimed at reducing sexually transmitted infections (STIs) across Australia. The introduction of the iStatis test aligns with Australia’s national strategy to enhance testing and improve health outcomes.

Addressing Public Health Concerns

The iStatis Syphilis Antibody Test is positioned as a key tool in addressing Australia’s public health challenges. As highlighted by Ana Subramanian, Vice President of Scientific Affairs at bioLytical, “Every congenital case of syphilis is preventable with timely testing and treatment.” She emphasized that rapid, point-of-care solutions are essential for expanding access to early diagnosis, particularly in clinical and outreach environments.

Manufactured in Canada, the iStatis test adheres to bioLytical’s stringent quality standards, being produced under the company’s MDSAP and ISO 13485:2016-certified Quality Management System. This ensures that each test not only delivers accurate results but also contributes to improving patient outcomes and advancing global public health objectives.

Healthcare professionals in Australia can obtain the iStatis Syphilis Antibody Test through authorized distributors or by reaching out directly to bioLytical Laboratories. For more detailed information about the product and its applications, interested parties can visit the company’s official website.

bioLytical Laboratories Inc. is dedicated to the research, development, and commercialization of rapid medical diagnostics, utilizing its proprietary INSTI technology platform and the iStatis line. By providing timely and accurate results, bioLytical aims to make a meaningful impact on public health challenges worldwide. For further details, please visit www.biolytical.com, www.insti.com, and www.istatis.com.